No registrations found.
ID
Source
Brief title
Health condition
Child; Cancer; Mucositis; Nutrition
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Nutritional state (weight, length, mid upper arm circumference)
Secondary outcome
- The degree of mucositis measured by plasma citrulline
- Quality of life (using Pedsqual questionnaire every 5 days and daily Cantrills ladder and VAS score)
- Number of infectious complications
- Number of bacteraemias
- Percentage of calculated optimal quantity of tube feeding actually given
- Liver toxicity scores according to NCI-CTCAE version 4.0
- Length of hospital stay
- Clinical symptoms of mucositis (NCI-CTCAE 4.0)
Background summary
In this project we will test which of two feeding strategies for children during chemotherapy induced mucositis is optimal, an elementary diet administered via continuous enteral drip, or total parenteral nutrition. The study will compare the two feeding strategies in a randomized crossover design. Children admitted to the UMCG for treatment of AML of B-NHL will be included. Using a crossover design, during two identical chemotherapy courses, each patient will get both the elementary diet and the total parenteral nutrition randomly with the nutritional state as primary outcome.
Study objective
Which of 2 feeding strategies for children during chemotherapy induced mucositis is optimal for the patient: an elementary diet, containing only simple macronutrients administered via continuous enteral drip; or total parenteral nutrition.
Study design
- Nutritional state: before start of the chemotherapy course and before start of the next course
- Plasma citrulline: every 2 days until next chemotherapy course
Intervention
Patients will be given standard nutrition(elementary diet administered via continuous enteral drip) or total parenteral nutrition during 2 identical chemotherapy courses. Using a crossover design, each patient will get both the standard diet and the study diet randomly.
W.J.E. Tissing
Groningen 9700 RB
The Netherlands
+31 (0)50 3614213
W.J.E. Tissing
Groningen 9700 RB
The Netherlands
+31 (0)50 3614213
Inclusion criteria
Children(0-18 years of age) admitted to the University Medical Center Groningen for the treatment of acute myeloid leukemia(AML) or B-Non Hodgkin lymphoma(B-NHL). They receive chemotherapy according to the Dutch Childhood Oncology Group(DCOG), for both AML and B-NHL containing at least 2 identical chemotherapy courses.
Exclusion criteria
-Patients and their parents are excluded when they are insufficiently capable of speaking and understanding the Dutch language.
-Patients are excluded when life expectancy is estimated to be below six months.
-No gastric tube in place in children who do eat during their chemotherapy (very rare) are excluded since we do not give a naso-gastric tube only for study purposes.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3937 |
| NTR-old | NTR4099 |
| Other | METc : 2013/094 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |